BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTIMA ACTIVATOR II REUSABLE DRIVE MECH

    MDR report key: 12606250 · Received October 11, 2021

    Report

    Report Number
    2242352-2021-00829
    Event Type
    Malfunction
    Date Received
    October 11, 2021
    Date of Event
    September 15, 2021
    Report Date
    February 24, 2022
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    DSW
    UDI-DI
    00607567700901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE # (B)(4). ANALYSIS OF PRODUCTION: (3331/213/67) THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WERE NO NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT NUMBER. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE MANUFACTURING PROCESS AND THE REPORTED FAILURE. HISTORICAL DATA ANALYSIS FOR SIMILAR COMPLAINTS: (4109/213/67) THERE WERE 2 ADDITIONAL SIMILAR COMPLAINT(S) REPORTED FOR THE REPORTED FAILURE MODE AND THE REPORTED LOT NUMBER. A REVIEW OF THE PRODUCT COMPLAINT TREND DATA WAS PERFORMED FOR THE MONTHS OF JUNE 2021¿ THROUGH ¿SEPT 2021. THE REVIEW DOES NOT IDENTIFY AN INCREASING TREND OR AN ADVERSE TREND FOR THREE CONSECUTIVE MONTHS FOR THE PRODUCT FAMILY AND THE FAILURE MODE. TREND ANALYSIS: (4110/213/67) THE OVERALL 24 MONTH PRODUCT COMPLAINT TREND DATA FOR THE PERIOD OCT 2019 THROUGH SEPT 2021 WAS REVIEWED. THERE WERE NO TRIGGERS IDENTIFIED FOR THE REVIEW PERIOD. COMMUNICATION/INTERVIEWS: (4111/213/67) COMMUNICATION/INTERVIEWS WERE PERFORMED TO OBTAIN ALL POSSIBLE INFORMATION. TESTING OF ACTUAL/SUSPECTED DEVICE: (10/13/22) THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 02/08/2022. AN INVESTIGATION WAS CONDUCTED ON 02/22/2022. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD WAS OBSERVED. BROWNISH DISCOLORATION WAS OBSERVED ON THE 200509 ENGRAVING AND THE PATENT NUMBER AS WELL AS ON THE ENGRAVED MAQUET. NO OTHER DISCOLORATION WAS OBSERVED. BASED ON THE RETURNED CONDITION OF THE DEVICE, THE REPORTED FAILURE "CORROSION" WAS CONFIRMED. THE DHR, SHOP FLOOR PAPERWORK WAS REVIEWED. THE VENDOR CERTIFIES THAT THIS DEVICE SERIAL/LOT CONFORMS TO ALL APPLICABLE PRODUCT SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    TRACKWISE ID# (B)(4). THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    RELATED TO (B)(4). THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, ULTIMA ACTIVATOR II REUSABLE DRIVE MECH HAS PITTING CORROSION / PITTING AFTER 4 WEEKS OF PREPARATION. MECHANICAL CLEANING IS CARRIED OUT WITH THE PRODUCT THERMOSEPT XTRA 0.5% FROM SCHÜLKE. NO IMPLANTATION OR USE ON THE PATIENT, BUT PITTING / RUST AFTER PROCESSING IN THE WASHER-DISINFECTOR

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1501914 ULTIMA ACTIVATOR II REUSABLE DRIVE MECH BAG, POLYMERIC MESH, PACEMAKER DSW MAQUET CARDIOVASCULAR LLC ULTIMA ACTIVATOR II REUSABLE DRIVE MECH 25153700 00607567700901

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown